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Associate Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Job Description
Associate Engineer
Top 3 Must Have Skill Sets:
- Knowledge of cGMP-Bio/Pharma background
- Project management and documentation
- Proven written and oral communication skills
Red Flags:
- Candidates who lack relevant skills
- Candidates who do not meet the qualification requirements
- Candidates who were separated from previous employment due to unethical behaviors
Summary:
This Associate Engineer position is in the Thermal Engineering Systems (TES) group at our company. The individual will lead TES project management and documentation. Under supervision by senior personnel, the individual will apply engineering principles and follow current SOPs to help execute the design, qualification and implementation of thermal packaging systems. In addition, the individual will assist transportation lab test execution, conduct experimental studies, and document the results following SOPs.
Responsibilities:
- Lead weekly team meetings to get project updates and discussion from TES team
- Update SharePoint dashboard (Project Management) to track project progress
- Participate in shipping solution qualification projects and trouble shootings
- Assist lab test execution and perform thermal experiments; conduct data analysis and generate report
- Author and revise controlled documents (SOPs, PCSs, RPTs, APPXs) in CDOCS and PLM system
- Collaborate with cross-functional teams on protocol review, testing preparation, change control process, and deviation & CAPA
- Use MS Office Suite (Excel, Word, Visio, PowerPoint, etc.) to create documents
- Track TES project progress and update project dashboard
- Author and revise controlled documents in document management system
- Assist lab test execution and conduct characterization studies for TES projects
- Participate in shipping solution qualification projects
Qualification:
- Engineering or Science degree; biotechnology, chemical or mechanical preferred;
- Prior lab experience/knowledge on pharmaceutical GMP&GDP;
- Prior project management, GdocP, commissioning;
- Good oral/written communication skills;
- Evidence of completing engineering tasks according to SOPs or instructions
Pay range is $25 - $30 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.